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The Effects of EndoActivator on Postoperative Pain and Root Canal Treatment Success

M

Medipol Health Group

Status

Completed

Conditions

Root Canal Infection
Periapical Periodontitis

Treatments

Procedure: Sonic Activation with EndoActivator
Procedure: Control Needle Irrigation

Study type

Interventional

Funder types

Other

Identifiers

NCT06339905
10840098-772.02-5564

Details and patient eligibility

About

This study evaluates postoperative pain and radiographic healing of asymptomatic posterior teeth with chronic apical periodontitis following root-canal treatment performed using EndoActivator for irrigation activation.

Full description

Aim: To evaluate postoperative pain and radiographic healing of asymptomatic posterior teeth with chronic apical periodontitis following root-canal treatment performed using EndoActivator for irrigation activation.

Methodology: In this clinical trial, root-canal treatment was performed on 140 posterior teeth with chronic apical periodontitis. After routine canal preparation, patients were assigned to either a control group treated using conventional needle irrigation (CNI) without activation or to sonic irrigation activation with EndoActivator. All treatment was completed in a single visit. Patients provided self-assessments of the severity of postoperative pain at 1, 2,3 and 7 days using a Verbal Rating Scale (VRS) and Wong Baker Face Scale. Patients were recalled at 12 months for clinical and radiographic examinations. Periapical healing was evaluated using a periapical index (PAI), with scores of 1 or 2 considered to represent treatment success and scores of 3, 4, or 5 to represent treatment failure. Data were analyzed using one-way ANOVA and Kruskal-Wallis tests, with differences of P < 0.05 considered statistically significant.

Enrollment

140 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 18-60 patient's age
  • Being systemically healthy
  • Having posterior teeth (molar or premolar) with chronic apical periodontitis lesion (PAI≥3)

Exclusion criteria

  • Clinically symptomatic teeth
  • Patients with complicated systemic disease (ASA 3 - 6)
  • Teeth with open apex
  • Teeth having curvature more than 20 degree
  • Not having enough tooth structure to be isolated with rubber dam
  • Patients with severe periodontal defects or deep periodontal pockets (probing depth> 4 mm)
  • A history of taking analgesics 12 hours ago or antibiotics 1 month ago
  • Patients who cannot come to control sessions

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

140 participants in 2 patient groups

Sonic Activation with EndoActivator
Experimental group
Description:
Sonic irrigation was performed using an EndoActivator sonic handpiece (Dentsply Tulsa Dental Specialties, Tulsa, OK, USA). A suitable-size activator tip was selected and loosely placed at 2 mm from working length, and the device was operated at 10,000 cycles/min using a pumping action to move the tip to produce vertical strokes of 2-3 mm.
Treatment:
Procedure: Sonic Activation with EndoActivator
Conventional needle irrigation (control)
Active Comparator group
Description:
Conventional needle irrigation was performed with short, in-and-out vertical strokes of 2-3 mm at a rate of approximately 100 strokes per minute.
Treatment:
Procedure: Control Needle Irrigation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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